Breast Implant Complications, Breast Implant Illness, Systemic Symptoms
Conditions
Keywords
Breast Implant Illness, Silicone Breast Implants, Persistent Systemic Symptoms, Explantation
Brief summary
This prospective controlled cohort will enroll women before primary aesthetic breast surgery. Women receiving silicone implants will be compared with women undergoing nonimplant mastopexy or reduction. Standardized systemic symptom, psychosocial, quality-of-life, and local breast assessments will be collected before surgery and through five years. The primary outcome is the incidence of a prespecified, adjudicated persistent new-onset multisystem symptom phenotype. Revision, explantation, local implant complications, and symptom changes after implant removal will also be evaluated.
Detailed description
The study addresses limitations of revision-only registry analyses by measuring symptoms before any implant exposure, including a contemporaneous nonimplant surgical control group, and applying a prespecified research phenotype rather than relying only on surgeon judgment or participant-requested BII labeling. Both cohorts will complete the same validated symptom and psychosocial battery at baseline, during early recovery, and annually through five years. Persistent cases will undergo multidisciplinary adjudication and clinically appropriate evaluation for alternative diagnoses. Implant complications, revision indications, and device characteristics will be recorded. A nested subcohort will measure symptom trajectories before and after explantation or exchange.
Interventions
Implant characteristics include manufacturer/lot when available, texture, shape, volume, pocket plane, incision route, and laterality. Exposure is chosen as clinical care before enrollment and is not assigned by the study. Linked arm/group(s): Silicone Breast Implant Cohort.
OTHERStandardized Systemic Symptom and Psychosocial Assessment
A locked battery will include validated measures of fatigue, pain interference, cognitive function, physical function, anxiety, depression, global health, and breast/body satisfaction. Proposed instruments include PROMIS short forms and BREAST-Q scales, subject to final licensing and language validation. Linked arm/group(s): Silicone Breast Implant Cohort, Nonimplant Breast Surgery Control Cohort.
Sponsors
Research Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female sex and age 18 years or older. * Planning primary aesthetic breast augmentation with silicone implants or planning nonimplant aesthetic breast surgery such as mastopexy or reduction. * No prior permanent breast implant. * Completion of the full baseline systemic-symptom and psychosocial assessment before surgery. * Ability to participate in annual follow-up for five years. * Written informed consent.
Exclusion criteria
* Breast reconstruction after cancer, prophylactic mastectomy, congenital deformity, or major trauma. * Known active autoimmune, inflammatory, neurologic, endocrine, infectious, or malignant condition expected to cause major systemic symptom change, unless the final protocol intentionally includes and stratifies these conditions. * Current pregnancy or breastfeeding. * Prior permanent breast implant or tissue expander. * Inability to complete validated questionnaires in the authorized language. * Planned simultaneous major surgery expected to dominate systemic recovery beyond the prespecified postoperative window.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of an Adjudicated Persistent New-Onset Multisystem Symptom Phenotype | 10 years | Proportion of participants who develop new or clinically meaningful worsening in at least two prespecified systemic symptom domains, persisting for at least 6 months, beginning after the initial 3-month postoperative recovery window, and not better explained by an alternative diagnosis after blinded adjudication. The final domain list and thresholds will be locked before enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Revision or Explantation Attributed to Systemic Symptoms | 10 years | Proportion undergoing implant exchange or explantation for participant-reported systemic symptoms or clinician-recorded BII/ASIA indication, reported separately from local complications and elective aesthetic reasons. |
| Change in Systemic Symptom Burden After Explantation or Exchange | 10 years | Within-person change in the prespecified symptom and PROM scores from the pre-revision assessment to 3, 6, and 12 months after explantation or exchange. |
Countries
Colombia
Contacts
CONTACTJuan Velez, MD, Plastic surgeon
PRINCIPAL_INVESTIGATORjuan velez, MD, plastic surgery
Outcome results
None listed